OrthAlign, Inc. announces US FDA clears ORTHALIGN PLUS™, the first handheld navigation device for use with both Total Hip and Total Knee Arthroplasty Surgeries
Aliso Viejo, CA (PRWEB) November 18, 2013 -- OrthAlign, Inc., a privately held medical device company, received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its ORTHALIGN PLUS™ system, a palm-sized, single-use navigation device for Total Hip Arthroplasty (for both anterior and posterior approaches) and Total Knee Arthroplasty surgeries.
“The FDA’s clearance of the OrthAlign Plus system provides an important new alternative in navigation technology for surgeons, specifically in Total Hip Arthroplasty surgery,” said Nick van der Walt, OrthAlign’s Vice President of Engineering. “Many surgeons have shared with us their challenges in being able to consistently position the acetabular cup at the desired inclination and anteversion. We are now uniquely able to provide surgeons with the tools they need to address those challenges and dramatically improve Total Hip Arthroplasty alignment.”
For Total Hip Arthroplasty surgery, the OrthAlign Plus system provides measurement accuracy of ±3°, with at least 95% confidence when measuring the angle of the shell impactor, relative to the frame of reference defined by the registered landmarks. The device has been tested and validated to achieve acetabular shell navigation accuracy for both inclination and anteversion.
“Cup orientation with conventional instruments has been challenging. While navigation systems have been available for over a decade and are known to improve accuracy, adoption has been low due to high capital equipment cost and disruption to surgical workflow. The OrthAlign Plus system provides comparable accuracy without these drawbacks,” said David J. Mayman, M.D., Clinical Co-Director of the Computer Assisted Surgery Center, Hospital for Special Surgery, New York, NY.
For Total Knee Arthroplasty surgery, KNEEALIGN® 2 is fully integrated into the OrthAlign Plus system, continuing to provide a reliable and efficient alternative to expensive Computer Assisted Surgery (CAS) systems, logistically arduous patient-specific cutting blocks, and invasive conventional methods used with an intramedullary rod. To date, KneeAlign has successfully been used in over 12,000 Total Knee Arthroplasty cases, demonstrating its accuracy to be comparable to traditional CAS systems, while providing better accessibility through greater ease of use, no need for capital investment, and significant lower cost per case.
Nick van der Walt further states, “Just as we have with the engineering of our KneeAlign system, OrthAlign has maintained its product development focus on providing accurate results, while fitting within the surgeon’s normal workflow and without significantly increasing procedure time. We are looking forward to the full commercial rollout of our OrthAlign Plus system.”
Indications for Use:
ORTHALIGN PLUS™ is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus system facilitates the accurate positioning of implants, relative to these alignment axes.
Example orthopedic surgical procedures include, but are not limited to:
• Total Hip Arthroplasty: Anterior/Posterior
• Total Knee Arthroplasty
About OrthAlign, Inc.
OrthAlign is a privately held medical device company committed to providing orthopedic surgeons with user-friendly, cost-effective, surgical navigation products for precise alignment. We believe that our technology will raise the standard of care in Total Knee and Total Hip Arthroplasty surgeries by making consistent and measurable results accessible to all surgeons, hospitals, and patients. Our strategy is to leverage this technology to provide simple and precise alignment solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit http://www.orthalign.com.
“ORTHALIGN®, ORTHALIGN PLUS™, KNEEALIGN®, and KNEEALIGN® 2 are [registered] trademarks of OrthAlign, Inc.”
James Young Kim, OrthAlign, Inc., http://www.orthalign.com, +1 949.525.9027, [email protected]
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